Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics  (Shanghai) Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, today jointly announced that they have entered into an exclusive license agreement for the development and commercialization of GenFleet's lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.

GFH925, GenFleet's lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies.

According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining the option-in rights for development and commercialization outside of China as well.  Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China.

GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets.

Dr Yongjun Liu, President of Innovent said, stated, "GenFleet has rich experience in research and development and has built up a proprietary pipeline of large and small molecule assets. We are delighted to form this strategic collaboration with GenFleet. Innovent is deeply engaged in the oncology area having built up a robust oncology pipeline of 20 clinical-stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of over 2000 people. KRAS G12C is an important mutation in multiple tumour types such as lung cancer and solid tumours. Innovent has established a wide coverage of major tumour types including lung cancer. The collaboration on GFH925 will explore its potentials in clinical trials for both monotherapy and combination therapy such as combination with PD-1 which can further enhance our coverage in the oncology area. By leveraging our synergy in clinical development and commercialization, we hope to expedite the development and launch of GFH925. Meanwhile, KRAS inhibitor has promising global market potential. With the option-in rights for global development and commercialization, we look forward to bringing GFH925 as a new and more effective treatment option to patients both in China and globally.

Dr Jiong Lan, CEO of GenFleet Therapeutics, stated, "We are pleased to announce our first major out-license collaboration with Innovent, an industry-leading biopharmaceutical company which has demonstrated many successful track records of developing and commercializing novel anti-cancer therapies. RAS used to be an undruggable target and there was no KRAS G12C inhibitor moving into the clinics when GenFleet started the program, which highlights our "globally new" pipeline strategy that focuses on novel mechanisms of action. The partnership is not only a recognition of GFH925, a KRAS/G12C inhibitor with potential best-in-class differentiation but also GenFleet's internal discovery and development capability as well.  The global scope of this collaboration will benefit not only patients in China but also those throughout the world. In addition, we share the same vision of swiftly tackling unmet medical needs and the same culture of agile R&D in a biotech setting.

Professor Yilong Wu, Director of Guangdong Lung Cancer Institute, stated, "KRAS mutation is widespread among patients of non-small cell lung cancer, pancreatic cancer, colorectal cancer, etc. Preclinical data have shown that GFH925 is differentiated from other KRAS G12C inhibiting products, and we look forward to positive results of GFH925's safety/tolerability and efficacy. Moreover, we will optimize our precision treatment plans and pave the way for the potential of combination therapies for patients with KRAS G12C gene mutation."